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Effectiveness of Acupuncture for Pain Control After Cesarean Delivery

医学 针灸科 安慰剂 致盲 可视模拟标度 患者满意度 安慰剂对照研究 随机化 不利影响 临床试验 麻醉 随机对照试验 物理疗法 外科 双盲 内科学 病理 替代医学
作者
Taras Usichenko,B. Henkel,Catharina Klausenitz,Thomas Heße,Guillermo Pierdant,Mike Cummings,Klaus Hahnenkamp
出处
期刊:JAMA network open [American Medical Association]
卷期号:5 (2): e220517-e220517 被引量:44
标识
DOI:10.1001/jamanetworkopen.2022.0517
摘要

Importance

A pharmacological approach to pain control after cesarean delivery is often insufficient on its own. Acupuncture is a promising method for mitigating postoperative pain and reducing postoperative opioid requirements.

Objective

To evaluate the efficacy and effectiveness of acupuncture as an adjunctive therapy for pain control after cesarean delivery, compared with a placebo intervention and standard care alone.

Design, Setting, and Participants

This single-center, placebo-controlled, patient- and assessor-blinded randomized clinical trial was conducted from January 13, 2015, to June 27, 2018, at a tertiary university hospital in Greifswald, Germany. Participants were women who were scheduled for elective cesarean delivery under spinal anesthesia and were randomized to either the acupuncture group (n = 60) or placebo group (n = 60). Another 60 consecutive patients who met the eligibility criteria and received the standard postoperative analgesia were selected to form a nonrandomized standard care group. The intention-to-treat analysis was performed from August 19, 2019, to September 13, 2019.

Interventions

In addition to standard pain treatment, each patient in the acupuncture group received auricular and body acupuncture with indwelling intradermal needles, whereas patients in the placebo group were treated with nonpenetrating placebo needles.

Main Outcomes and Measures

The primary outcome was pain intensity on movement, which was measured using an 11-item verbal rating scale. Secondary outcomes were analgesia-related adverse effects, analgesics consumption, time to mobilization and Foley catheter removal, quality of patient blinding to randomization, and patient satisfaction with treatment of pain.

Results

A total of 180 female patients (mean [SD] age, 31 [5] years) were included in the intention-to-treat analysis. The mean pain intensity on movement in the acupuncture group on the first postoperative day was lower than in the placebo group (4.7 [1.8] vs 6.0 [2.0] points; Cohend, 0.73; 95% CI, 0.31-1.01;P = .001) and the standard care group (6.3 [1.3] points; Cohend, 1.01; 95% CI, 0.63-1.40;P < .001). On the first postoperative day, 59 patients (98%) in the acupuncture group were fully mobilized vs 49 patients (83%) in the placebo group (relative risk [RR], 1.18; 95% CI, 1.06-1.33;P = .01) and 35 patients (58%) in the standard care group (RR, 1.69; 95% CI, 1.36-2.09;P < .001). The Foley catheter was removed in a total of 57 patients (93%) from the acupuncture group vs 43 patients (72%) from the placebo group (RR, 1.33; 95% CI, 1.12-1.57;P = .003) and 42 patients (70%) from the standard care group (RR, 1.37; 95% CI, 1.14-1.62;P = .002). Other parameters were comparable across the 3 study groups.

Conclusions and Relevance

Results of this trial showed that acupuncture was safe and effective in reducing pain and accelerating mobilization of patients after cesarean delivery. With consideration for personnel and time expenditures, acupuncture can be recommended as routine, supplemental therapy for pain control in patients after elective cesarean delivery.

Trial Registration

ClinicalTrials.gov Identifier:NCT02364167
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